Detection of Preterm Labour by Cervical Length
Antenatal Management Based on Transvaginal Ultrasound Cervical Length Screening for Preventing Preterm Birth
Study Overview
Status
Conditions
Detailed Description
- All pregnant women will attend hospital between 14-24 weeks and fulfil inclusion and exclusion criteria will be approached for possibility to be included in the study .
History taking .Obstetric history will be obtained from the patient includes gravidity and parity , last menstrual period , duration of gestation at birth time , mode of delivery , gender, birth Wight, any complication in each pregnancy, miscarriage and causes of miscarriage . Past history will be obtained from the patient for any medical disease like ( severe anaemia, hypertensive disease, heart disease, antiretroviral therapy in pregnancy and genitourinary infection) and History of cervical cercalage . Family history will be obtained to determine any history of family preterm birth. Socioeconomic status will be obtained include occupation and financial status. Special Habits for both couples.
- Gynaecological history will be taken from the patient include any vaginal bleeding, history of vaginal infection, operations like D and C with cervical dilatation.
- Examination Examination of the patient include vital signs, general examination ( head, neck ,chest ,heart ) obstetric examination include inspection, palpation, auscultation and speculum vaginal examination.
- -Investigation Investigation includes antenatal care laboratory tests like urine analysis ,CBC, RH factor and random blood sugar .
- Transvaginal ultrasound:
Study group : Cervical length will be measured using transvaginal ultrasonography with the standard longitudinal view of cervix while patient's bladder is empty. TVS probe will be used to measure cervical length. It will be measured by keeping the probe 3cm away from the posterior fornix. The cervical length is defined as the length between the internal OS and external OS
Those with short cervix less than 25 mm will be managed According to NICE guide lines :
Offer a choice of either prophylactic vaginal progesterone or prophylactic cervical cerclage to women: with a history of spontaneous preterm birth or mid-trimester loss between 16+0 and 34+0 weeks of pregnancy and in whom a transvaginal ultrasound scan has been carried out between 16+0 and 24+0 weeks of pregnancy that reveals a cervical length of less than 25 mm.
Discuss the benefits and risks of prophylactic progesterone and cervical cerclage with the woman and take her preferences into account.
Offer prophylactic vaginal progesterone to women with no history of spontaneous preterm birth or mid-trimester loss in whom a transvaginal ultrasound scan has been carried out between 16+0 and 24+0 weeks of pregnancy that reveals a cervical length of less than 25 mm.
Consider prophylactic cervical cerclage for women in whom a transvaginal ultrasound scan has been carried out between 16+0 and 24+0 weeks of pregnancy that reveals a cervical length of less than 25 mm and who have either: had preterm prelabour rupture of membranes (P-PROM) in a previous pregnancy or a history of cervical trauma (17) .
progesterone will be given in form of vaginal suppository 200 mg once daily . Start receiving it once diagnoses is established till 34 week gestation.
A McDonald cerclage will be be preformed for women once diagnoses is established and removed at 36 week gestational or when labour pain start.
Control group : All pregnant women who fulfil the same inclusion criteria, exclusion criteria, diagnoses established as short cervix by digital vaginal exam or trans abdominal ultrasound or not specified and do not undergo transvaginal ultrasound assessment , and do not managed according to NICE guide lines will be treated and managed according to their units as a control group.
• Then all patients will be followed up every 4 weeks by taking history , any complaint of new symptoms , compliance to treatment, obstetric exam and investigation if indicated till delivery and record the time of delivery or termination of pregnancy. After delivery, record maternal and fetal outcome.
Study Type
Enrollment (Anticipated)
Phase
- Early Phase 1
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- pregnant women with gestational age between 14-24 weeks and having singletone or multiple viable fetus
Exclusion Criteria:
.Current Cervical cercalage.
- Major Fetal malformation .
- Prenatal infection (bacterial vaginosis ) .Medical comorbidities . .Currently receiving Progesterone treatment. .Pregnancy from assisted reproductive technique . .Threatened miscarriage . .Rupture membrane. .Painful uterine contraction. .Low implanted placenta.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: control group not follow NICE guide lines
All pregnant women who fulfil the same inclusion criteria, exclusion criteria, diagnoses established as short cervix , and do not managed according to NICE guide lines will be treated and managed according to their units as a control group.
|
vaginal examination to detect short cervix
use abdominal ultrasound to measure cervical length
a medication is given to prevent uterine contraction
|
|
Experimental: study group follow NICE guide lines
- All pregnant women will attend hospital between 14-24 weeks and fulfil inclusion and exclusion criteria will be approached for possibility to be included in the study .
and will be managed according NICE guide lines
|
a transvaginal ultrasound is done to patient to determine cervical length
a progesterone vaginal suppository to prevent preterm labour
Mcdonald's cervical cercalage .
a stitch taken around the cervix to prevent preterm labour
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
preterm birth, defined as delivery before 37 weeks 0 days of gestation
Time Frame: baseline
|
determine number of patients with preterm birth under 37 week gastational age and trying to prevent early diagnosed conditions from 922 patient diagnosed with short cervix
|
baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean GA at delivery
Time Frame: baseline
|
detection of Mean gastational age at delivery
|
baseline
|
|
Birth Wight less than 2500 grams.
Time Frame: baseline
|
determine number of infants born from patients with short cervix and undergo management and record Birth Wight less than 2500 grams.
|
baseline
|
|
Birth Wight ( mean +SD) in grams
Time Frame: baseline
|
detection of Birth Wight ( mean +SD) in grams
|
baseline
|
|
compliance to medication.
Time Frame: baseline
|
determine if the 466 of study group patient taking the medication regularly as progesterone vaginal suppository by questioning the patient.
|
baseline
|
|
side effect related to intervention either progesterone or cercalage
Time Frame: baseline
|
detection and record the side effect related to intervention either progesterone or cercalage by questioning the patient
|
baseline
|
|
Mode of delivery
Time Frame: baseline
|
recording which patients deliver normal vaginal delivery or by cesarean section
|
baseline
|
|
perinatal mortality.
Time Frame: baseline
|
record the numbers of perinatal death who's mothers undergo treatment during pregnancy of overall 922 patients
|
baseline
|
|
Neonatal morbidity
Time Frame: baseline
|
record infants born to mother of study group and study group after birth with any morbidity like respiratory distress syndrome,necrotizing enterocolities,jaundice .
|
baseline
|
|
admission to Neonatal intensive care unit
Time Frame: baseline
|
determine which infant born will be admitted to the intensive care unit after delivery and record numbers of infants .
|
baseline
|
|
Maternal morbidity
Time Frame: baseline
|
record Maternal morbidity like maternal haemorrhage , maternal infection ,maternal medication from 922 patients with short cervix.
|
baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alaa Eldeen M Ismail, MD, Asssiut University
- Principal Investigator: Ahmed M Alaa eldeen, MD, Assiut University
- Principal Investigator: Hany A Ali, MD, Asssiut University
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VUS cervical Length
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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